On February 15, 2022, good news came from the partners of Clindata Pharmaceutical Biotechnology (Beijing) Co., Ltd. (hereinafter referred to as "Clindata^®"): the partners and Clindata^® Sino-US The Pre-IND data of the bridging clinical trial completed by the Shuangbao team has been submitted at CDE today.

Starting from this IND service bidding, the Sino-US double-reporting team of Clindata^® has analyzed the project data, and won the recognition of partners with the unique innovative bridging clinical trial design strategy of Clindata^®, and won the approval from many bidders. stand out. In the process of writing Pre-IND materials, through professional analysis and in-depth communication with domestic and foreign partners and researchers, the optimal bridging strategy is provided for partners.

Adhering to the service tenet of turning customers into global innovative drug R&D leaders, this project only spent two hours in the process of obtaining the product's previous trial data to analyzing and completing the strategy formulation, protocol design, and preparation of Pre-IND data for the bridging clinical trial. more than a month. During the whole process of writing the Pre-IND data, Clindata^® maintained high-frequency and efficient communication with the partner team, which improved the success rate of drug bridging clinical trials and shortened the time to market. Clindata^® adopted exclusive bridging clinical trials. The trial decision-making system, under the premise of meeting the requirements of the national bureau and ICH, designs and writes the most suitable clinical trial plan with short implementation time, high quality, low sample size and high success rate.

The Pre-IND meeting is the initial stage of drug clinical trials. There is still a period of time from the submission of Pre-IND data to the IND implied license. Currently, it is only the beginning of the clinical development of new drugs. We will go all out to support our partners and work together to achieve the successful implementation of the bridging trial, help the drug launch, and benefit patients.

Clindata^® will not forget the original intention of taking the patient as the center, scientific clinical practice to achieve human health, keeping in mind the mission of developing new drugs to cure tumors and other major diseases, and forging ahead!